Visual imaging system for ultrasonic probe

ABSTRACT

A non-invasive visual imaging system is provided, wherein the imaging system procures an image of a transducer position during diagnostic or therapeutic treatment. In addition, the system suitably provides for the transducer to capture patient information, such as acoustic, temperature, or ultrasonic images. For example, an ultrasonic image captured by the transducer can be correlated, fused or otherwise combined with the corresponding positional transducer image, such that the corresponding images represent not only the location of the transducer with respect to the patient, but also the ultrasonic image of the region of interest being scanned. Further, a system is provided wherein the information relating to the transducer position on a single patient may be used to capture similar imaging planes on the same patient, or with subsequent patients. Moreover, the imaging information can be effectively utilized as a training tool for medical practitioners.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application is a continuation of U.S. patent application Ser. No.13/071,298, entitled “VISUAL IMAGING SYSTEM FOR ULTRASONIC PROBE,” filedon Mar. 24, 2011, issued as U.S. Pat. No. 8,409,097 on Apr. 2, 2013,which is a continuation of U.S. patent application Ser. No. 11/554,272,entitled “VISUAL IMAGING SYSTEM FOR ULTRASONIC PROBE,” filed on Oct. 30,2005, issued as U.S. Pat. No. 7,914,453 on Mar. 29, 2011, which was acontinuation-in-part application of U.S. patent application Ser. No.10/358,110, entitled “VISUAL IMAGING SYSTEM FOR ULTRASONIC PROBE,” filedon Feb. 4, 2003, issued as U.S. Pat. No. 7,142,905 on Nov. 28, 2006,which was a continuation application of U.S. patent application Ser. No.09/750,816, entitled “VISUAL IMAGING SYSTEM FOR ULTRASONIC PROBE,” filedon Dec. 28, 2000, issued as U.S. Pat. No. 6,540,679 on Apr. 1, 2003,both incorporated herein by reference.

FIELD OF THE INVENTION

This invention generally relates to a non-invasive ultrasonic system,and more particularly, to a system which is capable of generatingultrasonic imaging data and information related to the positioning of atransducer during medical treatment and diagnosis.

BACKGROUND OF THE INVENTION

There are a number of well-known non-invasive imaging techniques for thediagnosis and treatment of patients. These techniques generally allow aphysician to obtain high fidelity views of the human anatomic structurewithout the advent of invasive procedures. Such imaging systems whichprovide a cross-sectional (tomographic) view of the human body includecomputer-aided tomography (CAT scans) x-ray imagers, magnetic resonance(MRI) imagers, positron emission tomographic scanning (PET), andmagnetoencephotographic scanning (MEG). Typically, when a patient isscanned using one of these conventional cross-sectional imagingtechniques, the patient's entire body or limb is imaged or mapped andthe resulting anatomic topology is stored in an imaging database forlater use.

While CAT scans, MRI's, PET's, and MEG's allow imaging of the entirebody or entire limb requiring treatment, ultrasonic hand-heldtransducers are generally used to obtain a more localized image of atreatment area. In general, the hand-held transducer contains an imagingelement which includes an ultrasonic sensor for placing in contact withthe patients skin. During operation, the imaging element of thetransducer sends ultrasonic waves from the transducer into the patient'sbody to the region of interest, and scattered waves reflected from theregion of interest within the body are collected by an ultrasonic sensorwithin the transducer. The resulting electrical signals can then beprocessed to produce an image corresponding to the structure imaged bythe transducer.

Many imaging systems, such as, those described above, include a featurethat allows the operator to indicate the source or location of thescanned image. In particular, the operator makes use of a model patternrepresenting the human body. In marking the location of the recordedimage, the operator places a specially configured cursor representingthe image plane of the scanning device over a model pattern toillustrate the imaging plane's orientation with respect to the patient'sbody.

For hand-held transducers, however, any movement of the transducer'sorientation with respect to the patient's body changes the orientationof the imaging plane. This change in the imaging plane thereby requiresthe operator to readjust the specially configured cursor with respect tothe model pattern. As a consequence, if the patient's body shiftsbetween taking images, or if the transducer must be repositioned afterimaging, it is often difficult to recapture the prior image location.

Moreover, an additional problem associated with the aforementionedscanning techniques is that each imaging process is particular to apatient, and thus sensitive to the patient's position with respect tothe imaging device. Therefore, each set of images has a discrete, uniqueorientation related to a single patient resulting from a single scanningsession. Because of their unique or distinct features, images formed atdifferent times, or from different vantage paints cannot be suitablycompared on a point-by-point basis. This prevents an accurate comparisonof the scanning regions from one scanning session to another, and fromone patient to another. Such a comparison would be desirable in caseswhere the practitioner wishes to accurately compare scanned images froma healthy patient to the images of the patient undergoing the treatment,or where a practitioner wants to assess the responsiveness orimprovements of a patient to a particular treatment. When such acomparison is desired, a system which enables the practitioner to placea transducer or other medical device in a prior imaging position wouldbe tremendously beneficial.

Prior art systems for aiding or guiding the positioning of medicaldevices are generally cumbersome and complex. For example, U.S. Pat. No.5,748,767 issued to Raab discloses a method for aiding a medicalpractitioner in the re-positioning of a surgical tool in a priorlocation, such as when the patient has mewed. This re-positioning of theapparatus is accomplished by providing a correlation between thecoordinates of the pre-treatment image and the image acquired during thetreatment procedure. In addition, Raab necessarily requires the use ofan apparatus which can transpose the imaging information from thereference system of the imaging system to the reference system of theapparatus. The system disclosed in Raab provides a method to enable thesurgical tool to be positioned and re-positioned in relatively the sameposition with an acceptable accuracy by coordinating the pre-treatmentand treatment reference systems.

During operation of the Raab system, the pre-treatment and treatmentcoordinates are continually calculated with respect to a speciallydesigned reference block attached to an electrogoniometer. Theelectrogoniometer is further used to determine the orientation of theinstruments used in the treatment process. This system, however, uses amechanical linkage for maintaining the surgical tool in a fixedrelationship with the reference block. Such machinations of the probingprocess creates a system that is relatively cumbersome for thepractitioner using a hand-held transducer.

An additional problem with existing systems is found in the difficultywith which a prior imaging plane can be recaptured for comparisonpurposes, a problem which becomes even more significant with the use ofhand-held transducer. For example, in one therapeutic application usinga hand-held transducer, the objective of the treatment is to create avery well-placed thermal gradient in the treatment area to selectivelydestroy certain regions thereof. An example of this is the hypothermiatechnique wherein a temperature near about 43 degrees Celsius isrequired to be maintained in the specific treatment area, or the focusedultrasound surgery technique which has a goal of elevating the treatmentarea temperature to above and beyond 55 degrees Celsius. During thetherapeutic treatment process, the physiological response of the targettissue is directly related to the spatial extent and temporal durationof the heating pattern. Consequently, in order to appropriately performfeedback and control of the therapeutic treatment process, it isabsolutely essential to control the temperature in the target tissue soas to know whether or not the temperature in the treatment region hasbeen raised to a level that produces a desired therapeutic effect or thedestruction of the tissue. Moreover, as with the hypothermia and focusedultrasound surgery techniques, and any other technique whereby thesuccess of the therapy must be evaluated from one treatment session tothe next, it is critical to be able to accurately image the treatmentarea undergoing treatment for comparison to subsequent treatmentsessions.

Another method for enabling a particular image to be recaptured from onesession to the next may be accomplished by using a three-dimensionalcoordinate system that is fixed within a human anatomy. For example,U.S. Pat. No. 5,230,338 issued to Allen at al discloses a method forinteractively guiding a surgical tool, wherein three or more fiducialimplants are implanted in three separate, spaced locations within thehuman body. With the Allen method, the three fiducial implants arearranged in a non-collinear manner such that a plane is formed whichdefines a three dimensional coordinate system. Once the externalcoordinate system is established, a scan of the treatment area isperformed. During subsequent scans, the patient's orientation may changerelative to the imaging apparatus, but the new orientation of thepatient can be measured by locating the fiducial implants to relation tothe imaging apparatus. In this manner, the images of subsequent scans ofa patient relating to a new position or orientation can be configured tocorrespond to the earlier recorded scans for comparison. A disadvantageinherent in the Allen system, however, is that the fiducial implantsremain implanted in the patient between imaging session. In addition,the Allen system does not facilitate the scanning or diagnosis of otherpatients, but only operates effectively for the same patient.

As described above, several prior art techniques exist for monitoringand recording the position of tools used in the diagnosis and treatmentof patients, or for recapturing an image scanned in a prior scanningsession. Generally, these techniques are complex as in the U.S. Pat. No.5,748,767 issued to Raab, or are limited in their use, as in U.S. Pat.No. 5,230,338 issued to Allen et al. That is, use of such techniquesessentially requires the implementation of cumbersome equipment, such asan electrogoniometer and reference block, or requires that elements ofthe system remain with the patient between scans, such as the implantsin Allen. In that regard, such methods are inadequate for medicalspecialist who desire a simpler and less cumbersome manner to record atool position or orientation which correlates with a prior image, tofacilitate the return to the precise location of the prior treatment inthat patient or, alternatively, a second patient undergoing similartreatment.

Thus, a need exists for a less cumbersome and easy to use system capableof monitoring and recording the position of a transducer to facilitatethe desired-positioning of the transducer within a treatment area.

SUMMARY OF THE INVENTION

A visual imaging system in accordance with the present inventionovercomes various problems of the prior art. In accordance with variousaspects of the present invention, a non-invasive visual imaging systemis provided, wherein the imaging system procures an image of atransducer position during diagnostic or therapeutic treatment. Thevisual imaging system may comprise a laser, an LED, a photodiode, or anyother light sensor or emitter devices, or any combinations thereof, forcapturing visual information regarding the position of the transducerduring diagnostic or therapeutic treatment. In addition, the systemsuitably provides for the transducer to capture patient information,such as acoustic, temperature, or ultrasonic images. For example, anultrasonic image captured by the transducer can be correlated orotherwise fused or combined with the corresponding positional transducerimage, such that the corresponding images represent not only thelocation of the transducer with respect to the patient, but also theultrasonic image of the region of interest being scanned.

In accordance with another aspect of the present invention, the imagingsystem can comprise a positioning indicator located within thetransducer which can facilitate the determination of the position and/ororientation of the transducer with respect to the patient. In addition,this positioning information can be utilized to suitably scale theultrasonic image of the treatment region to correspond with thepositional image of the patient to provide a fused image.

Further, in accordance with another aspect of the present invention, asystem is provided wherein the information relating to the transducerposition on a single patient may be used to capture similar imagingplanes on the same patient, or with subsequent patients. Thisinformation captured may also be utilized for training poses.

BRIEF DESCRIPTION OF THE DRAWINGS

A more complete understanding of the present invention may be derived byreferring to the various exemplary embodiments of the present inventionwhich are described in conjunction with the appended drawing figures inwhich like numerals denote like elements, and in which;

FIG. 1 illustrates a block diagram of an exemplary embodiment inaccordance with the present invention;

FIG. 2 illustrates a block diagram of another exemplary embodiment inaccordance with the present invention;

FIG. 3 illustrates an exemplary embodiment of a probe assembly inaccordance with the present invention;

FIGS. 4A-4F illustrate an exemplary embodiment of an attachment devicein accordance with the present invention;

FIG. 5 illustrates another exemplary embodiment of a probe assembly inaccordance with the present invention;

FIG. 6 illustrates an exemplary embodiment of the visual imaging systemin operation in accordance with the present invention;

FIG. 7 illustrates an exemplary combined image capable of being shown onthe display screen in accordance with the present invention;

FIG. 8 illustrates another exemplary combined image capable of beingshown on the display screen in accordance with the present invention;

FIG. 9 illustrates yet another exemplary combined image capable of beingshown on the display screen in accordance with the present invention;and

FIG. 10 illustrates an exemplary embodiment of the visual imaging systemin operation as may be displayed in accordance with the presentinvention.

DETAILED DESCRIPTION OF VARIOUS EXEMPLARY EMBODIMENTS

The present invention may be described herein in terms of variouscomponents and processing steps. It should be appreciated that suchcomponents and steps may be realized by any number of hardwarecomponents configured to perform the specified functions. For example,the present invention may employ various medical treatment devices,visual imaging and display devices, input terminals and the like, whichmay carry out a variety of functions under the control of one or morecontrol systems or other control devices. In addition, those skilled inthe art will appreciate that the present invention may be practiced inany number of medical contexts and that the exemplary embodimentrelating to an ultrasonic transducer as described herein is merely oneexemplary application for the invention. For example, the principles,features and methods discussed may be applied to any medicalapplication. Further, various aspects of the present invention may besuitably applied to other industrial, manufacturing or engineeringapplications, such as the inspection of materials such as steel,plastics, concrete or wood.

In accordance with one aspect of the present invention, a medicaltreatment and diagnosis system comprises a visual imaging systemsuitably configured with a probe assembly to facilitate the accurate andconsistent placement of the probe assembly during treatment anddiagnosis of a patient. The probe system can be suitably configured toperform any of various functions, such as the obtaining of informationrelating to a region of interest of the patient, and/or the providing oftherapeutic treatment of the region of interest. In addition, the probesystem can comprise various medical devices, such as transducers forimaging, heating or temperature measurement, audio devices, or any otherdevice for obtaining patient information.

The visual imaging system is suitably configured to provide informationrelating to the position of the probe system with respect to thepatient, or the region of interest. This information can include variousforms, such as, for example, video or photographic images, or graphicalrepresentations, relating to the position of the probe system duringoperation. Moreover, the visual imaging system can comprise variouscomponents, such as video or other like imaging devices. In addition,the visual imaging can be configured directly within, or connected to,the probe system facilitate the identification of the positionalinformation of the probe system during its use.

In accordance with another aspect of the present invention, the visualimaging system is suitably configured to provide information relating tothe position of the probe system to a control system for furtherassessment and recommendations. In accordance with this aspect, thecontrol system is configured to receive imaging information from thevisual imaging system and patient information from the probe system andsuitably correlate both components of information to provide variousadvantages to the medical practitioner. For example, the control systemcan provide information which facilitates the positioning of the probesystem during use. This information could be a reference position of theprobe system from a prior use of the probe with a particular patient, orfrom other patients. In addition, the control system could provideinformation directing the probe system to a specific position of thepatient to observe or treat a particular region of interest for thatpatient. Further, this imaging information can be suitably utilized forthe training of medical practitioners.

To further explain in more detail various aspects of the presentinvention, exemplary embodiments of a visual imaging system as used witha control system and an ultrasonic probe system will be provided.However, it should be noted that the following exemplary embodiments arefor illustrative purposes, and that the present invention can comprisevarious other configurations for a medical treatment and diagnosticsystem. In addition, although not illustrated in the drawing figures,the medical treatment and diagnostic system can further includecomponents associated with a therapy or diagnostic system, such as anyrequired power sources, system control electronics or additional memorylocations.

With reference to FIG. 1, an exemplary embodiment of a medical treatmentand diagnostic system in accordance with the present invention is shown.In accordance with this embodiment, the system comprises a probeassembly 118 and a control system 100. Probe assembly 118 suitablycomprises a transducer 102 for rendering localized diagnosis andtreatment of patients and a visual imaging system 116 far transmittinginformation to control system 100 relating to the position and/ororientation of transducer 102 with respect to the patient. Transducer102 may comprise any conventional type of transducer used bypractitioners in the diagnosis or treatment of patients. Preferably,transducer 102 comprises an ultrasonic transducer configured to providevarious features. For example, transducer 102 can include a visualimaging element capable of imaging a patient's treatment region.Transducer 102 can also be configured for recording or measuringacoustic or temperature data and for transmitting the acoustic ortemperature data to the control unit 100 via communications channel 104.Further, transducer 102 can be suitably configured to providingtherapeutic treatment to the region of interest. In accordance with anexemplary embodiment, transducer 102 can comprise a combined imaging,therapy, and temperature measurement transducer, as disclosed more fullyin U.S. Pat. No. 6,050,943, entitled IMAGING THERAPY AND TEMPERATUREMONITORING ULTRASONIC SYSTEM and issued on Apr. 18, 2000, as well as athree-dimensional ultrasonic image as disclosed more fully in U.S.patent application Ser. No. 09/502,174, now U.S. Pat. No. 6,500,121,entitled IMAGING, THERAPY AND TEMPERATURE MONITORING ULTRASONIC SYSTEM,both hereby incorporated herein by reference.

Visual imaging system 116 may comprise any conventional device capableof capturing visual information relating to the position and/ororientation of transducer 102 and for transmitting the information tocontrol device 100, via such as signal cable 120. For example, imagingsystem 116 can comprise a video camera for capturing real-time orsubstantially-real-time visual information. Visual imaging system 116can also comprise a photographic camera for providing still-photosrepresentative of the position and/or orientation of transducer 102. Inother embodiments, the visual imaging system 116 may comprise one of alaser, an LED, a photodiode, or any other light sensor or emitterdevices, or any combinations of such lasers, LEDs, photodiodes, or anyother light sensor or emitter devices, for capturing visual information.

In addition, visual imaging system 116 can be suitably connected totransducer 102 to follow the movement of transducer 102 duringoperation. As a result, a transducer 102 moves about the patient, visualimaging system 116 can suitably follow along in real-time. Thisconnection can be facilitated by various devices and in various manners.In addition, visual imaging system 116 can be permanently or removeablyattached to transducer 102. Further, the position and/or orientation ofvisual imaging system 116 with respect to transducer 102 can be suitablyconfigured in various manners, as will be described in more detailbelow. As a result, the positional and/or orientation information oftransducer 102 can be correlated with any imaging, acoustic ortemperature measurements obtained by transducer 102.

Control system 100 is configured to control the operation of probeassembly 118, including the receiving of information from probeassembly, such as from transducer 102 and imaging system 116. Inaddition, control system 100 can be configured to process theinformation collected from transducer 102 and imaging system 116. Fromthis processed information, control system 100 can provide various typesof information to the medical practitioner.

For example, control system 100 can indicate to the practitioner adesired position and/or orientation of transducer 102 based on the prioruse of probe assembly 118 with the present patient being observed. Inaddition, control system 100 can also provide information based on useof probe assembly 118 for other patients. Moreover, control system 100can include a historical database of previous applications of probeassembly 118. This database can provide position and/or orientationinformation for a particular region of interest, and can be utilized forfurther review and diagnosis of the patient, as well as being used fortraining of medical practitioners.

Control system 100 can comprise various hardware configurations. Inaccordance with an exemplary embodiment, control system 100 comprises amemory unit 106, a central processing unit 108, and a display device110. The memory unit 106 of control system 100 may be of anyconventional type capable of storing a plurality of data and softwareprograms, including video, audio, numerical or statistical data. Memoryunit 106 is suitably configured to provide memory locations for storingvarious items of data to be directly or indirectly input to, or directlyor indirectly output from, control system 100. Memory unit 106 can alsocomprise a conventional database for the storage of a plurality of dataand software programs, including video, audio, numerical or statisticaldata. For example, video streaming of the positional imaging informationand ultrasonic imaging information of transducer 102 during operationmay be suitably stored, such as a segment of a couple seconds, minutesor longer, or even still segments of information.

Memory unit 106 can be connected to central processing unit 108 in anyconventional manner, such as, for example, through a bus 114. Centralprocessing unit 108 is configured for receiving and decoding incominginstructions, executing commands, and manipulating data stored in memoryunit 106. Central processing unit 108 may also be configured to receiveinstructions from an input device 112, such as any conventional typekeyboard, for example, a touch-type or touch entry keyboard. Theinstructions from the input device 112 may further require the centralprocessing unit 108 to retrieve data or software programs stored inmemory unit 106. Central processing unit 108 is further capable ofexecuting computer software programs and sending the processedinformation to display device 110.

Central processing unit 108 may comprise various software algorithmsconfigured for correlating, fusing or otherwise combining acoustic,thermal, or ultrasonic imaging information from transducer 102 with thepositional and/or orientation information from imaging device 116. Forexample, in accordance with an exemplary embodiment, and with momentaryreference to FIGS. 7-10, the software algorithms can be configured toprovide a combined image wherein the positional image of transducer 102can be suitably displayed with the ultrasonic image of the patient toprovide a “fused” image. In addition, such a fused or combined image canbe suitably scaled to as to appear to provide a cross-sectional view ofthe patient and treatment region during operation of transducer 102.

Display device 110 suitably comprises any display for providing at leastone of video, audio, graphical data or images. Display device 110 may bea component of control system 100, or display device 110 may be aseparate device from control system 100, for example as is depicted inFIG. 2. Where display device 110 is apart from control system 100 as inFIG. 2, display device 110 can be connected to the control system 100via communications channel 204. Further, display device 110 may also beof any conventional type capable of displaying data input through inputdevice 112, stored in memory unit 106, or processed through processingunit 108. For example, display device 110 is capable of displaying videoand ultrasonic images in simultaneous or singular fashion, for example,a fused image or separate images of the position of transducer 102 andthe ultrasonic image of the patient.

Referring now to FIG. 3, an exemplary embodiment of probe assembly 118is illustrated. In accordance with this embodiment, transducer 102further includes a transducer imaging element 306 encased within atransducer housing 304. Transducer imaging element suitably comprises aultrasonic transducer element configured for sending ultrasonic signalsto a region of interest and then suitably receiving signals to providean ultrasonic image of the region of interest.

Visual imaging device 116, such as a video camera, can be suitablyattached or connected to transducer 102 by various manners. For example,to connect imaging device 116 and transducer 102, an arm member 122 canbe provided. Arm member 122 may be any configuration of attachmentstructure, and may comprise various materials, for example, plastics,metals or other like materials. In accordance with one embodiment, armmember 122 is adjustable. In this embodiment, arm member 122 can besuitably configured for moving with relative freedom to enable imagingdevice 116 to be suitably stationed in various positions with respect totransducer 102, i.e., the arm member can position imaging device 116 invarious fixed positions with respect to transducer 102 to providemultiple views of transducer 102 with respect to the patient. Forexample, arm member can comprise a section of flexible conduit, such asthat utilized in various adjustable lighting systems. Thus arm member122 can be suitably positioned, and/or re-positioned as desired by themedical practitioner. However, arm member 122 can also comprise a rigidor substantially rigid member configured to maintain a more permanentposition of imaging device 116 relative to transducer 102. Accordingly,arm member 122 suitably facilitates the procurement of images relatingto the position of the transducer 102 from imaging device 116 byproviding a fixed position of imaging device 116 with respect totransducer 102 during operation.

Arm member 122, and thus visual imaging system 116 can be suitablyattached or connected to transducer 102 in various manners. For example,transducer 102 can suitably include an attachment device 302. Attachmentdevice 302 can be permanently or removeably affixed to transducer 102such that when affixed, attachment device 302 is in continuous contactwith the transducer housing 304 In addition, attachment device 302 canprovide for the fixed connection of arm member 122 to transducer 102.Attachment device 302 can also comprise any material, for example,plastics, metals, wood and the like, and any configuration, for example,clamps, clips, clasps and the like, for facilitating connection orattachment of arm member 122 to transducer 102.

With momentary reference to FIGS. 4A through 4F, various perspective,top, bottom and side views of an exemplary attachment device 302 areillustrated. In this embodiment, the attachment device 302 comprises aclip 402. As shown, clip 402 is suitably designed as to be capable ofbeing securely attached to transducer housing 304. In addition, theinner contour 400 of clip 402 is preferably shaped to the outer contourof transducer housing 304 such that once clip 402 is firmly attached totransducer housing 304, the position of clip 402, relative to transducerhousing 304, is substantially fixed. As a result of attachment device302 and arm member 122, the visual image transmitted by imaging device116 can follow in a direct correlation to the movement and position oftransducer 102.

Although FIG. 4 depicts a clip 402 wherein the clip is formed to fitsecurely and immobile to a transducer housing, it should be noted thatclip 402 is not so limited. That is, imaging device 116 and arm member122 may be affixed to the transducer housing 304 using any conventionalmechanism which ensures that once arm member 122 is held substantiallyrigid or fixed, then the spatial relationship between imaging device 116and transducer 102 remains substantially fixed. Accordingly, attachmentdevice 302 may comprise any assembly or arrangement such that theattached components are rendered relatively fixed with respect to oneanother.

Although an attachment device 302 can facilitate attachment of armmember 122 to transducer 102, other methods and devices for connectingthe components together can be utilized. For example, arm member 122 andtransducer 304 can be suitably configured for integration of arm member122 directly into transducer 102. With reference to FIG. 5, anotherexemplary embodiment of probe assembly 118 is illustrated. In accordancewith this embodiment, a transducer 502, including a transducer housing504 and transducer imaging element 506 are provided. In addition, an armmember 522 is suitably integrated into transducer housing 504. Further,this exemplary embodiment of the probe assembly 118 includes imagingdevice 516 attached to transducer 502 via arm member 522. It should benoted that transducer 502, imaging device 516 and arm member 522 aresimilar in characteristics and operation to transducer 102, visualimaging device 116 and arm member 122 described above. In addition,probe assembly 118 includes a transducer cable 520 which is capable oftransmitting data from transducer sensor 506 and visual images fromimaging device 516 to control unit 100.

In accordance with another aspect of the present invention, probeassembly 108 may be configured to provide a fused image for displaywhich is representative of the combining of the position and/ororientation information of transducer 102 and the ultrasonic imaginginformation of the treatment region. This fusing of images can besuitably provided by software algorithms within control system 100.While this fusing of images can be readily provided once the orientationand position of transducer 102 is known, once transducer 102 is moved ortilted such that the angle of scan or the geometry of transducer 102with respect to the patient changes, the scaling of the ultrasonicimaging information needs to be reconfigured.

To further facilitate the providing of a fused image which represents animage similar to a cross-sectional view of transducer 102 and patient,for example, as illustrated in FIGS. 7-10, transducer 102 can beconfigured with a positioning indicator. With reference to FIG. 3, anexemplary positioning indicator 308 is illustrated.

In accordance with this exemplary embodiment, positioning indicator 308comprises a series of marks which are suitably configured to facilitatethe determination and assessment of the positional and/or orientationinformation of transducer 102 with respect to the patient. Positioningindicator 308 is suitably configured to permit control system 100 tosuitably correlate the geometry, i.e., position and orientation, oftransducer 102 to the geometry of a corresponding ultrasonic image ofthe treatment region. For example, positioning indicator 308 cancomprise triangulation marks, i.e., three marks configured in atriangular manner, configured at known distances apart to permit thesoftware algorithm of central processing unit 108 to assess anddetermine the orientation and geometry of transducer 102 duringoperation.

For example, transducer 102 can include three cross-like triangulationmarks, 1 mm in length, separated by fixed distances, e.g., 3 to 10 mm ormore apart, that can provide the software with a reference point for theorientation of transducer 102. In addition, by knowing the fixeddistances of the triangulation marks, the software within centralprocessing unit 108 can determine the position and distance of imagingdevice 116 with respect to transducer 102. Thus, as transducer 102changes the angle of scan or otherwise the orientation with respect tothe region of interest, the software within central processing unit 108can suitably follow these changes in orientation and position.Accordingly, by knowing the orientation and geometry of transducer 102with respect to the patient, positional and/or orientation informationand ultrasonic imaging information can be suitably fused into a combinedimage. In addition, the respective positional and/or orientationinformation and ultrasonic imaging information can be suitably scaled bythe software algorithm to provide an image similar to a cross-sectionalview of transducer and treatment region, such as is illustrated in FIG.10.

While an exemplary embodiment of a positioning indicator can comprise aseries of marks 308, such as two, three, four or more, or a single mark,positioning indicator 308 can comprise any mechanism for facilitatingthe determination of the geometry of transducer 102 with respect to thepatient. Thus, the positioning indicator can also comprise anythree-dimensional positioning indicator devices that can provideinformation regarding the position of transducer 102 with respect to thepatient. For example, the positioning indicator can comprise anelectromagnet; device configured within transducer 102 that can besuitably tracked electromagnetic sensors configured with control system100. In addition, the positioning indicator can comprise a gravitationalaccelerometer configured to provide the assessment of three axis orrotation of transducer 102 in three dimensions. Such a collection ofthree-dimensional information could also be suitably correlated withthree-dimensional imaging information, as disclosed more fully in U.S.patent application Ser. No. 09/502,174, now U.S. Pat. No. 6,500,121,entitled IMAGING, THERAPY AND TEMPERATURE MONITORING ULTRASONIC SYSTEM,hereby incorporated herein by reference.

Having described various aspects and features of a probe assembly andcontrol system, the operation of an exemplary embodiment of the presentinvention will now be described. With respect to the followingdescription, the operation of ultrasonic transducers will not bedescribed in great detail. Although the present embodiment will bedescribed with respect to the use of an ultrasonic transducer, it is tobe understood that the present invention is not so limited. For example,the present invention may be used with any extra-corporeal probe ortransducer used in the diagnosis or treatment of patients, such asgeneral radiology, OB/GYN, breast, musculoskeletal, and other imaging ortreatment applications.

With reference to FIG. 6, an exemplary embodiment of the presentinvention during operation is illustrated. In accordance with thisembodiment, a patient 650 is illustrated lying on a treatment table 660while undergoing treatment or diagnosis in accordance with the presentinvention. The medical treatment and diagnosis system includes a controlsystem 600 and a display device 610, wherein both the control system 600and the display unit 610 comprise characteristics to the like elementsof FIGS. 1 and 2. Further, a probe assembly 618 is included forproviding imaging and treatment features, such as the probe assemblydescribed in more detail above.

During operation, the medical practitioner, not shown, can manuallyimage a treatment area of patient 650 by scanning the patient with probeassembly 618. Transducer 602 of probe assembly 618 images the treatmentarea and sends an ultrasonic image to the control system 600 via datacable 620. Meanwhile, visual imaging device 616, such as a video camera,of probe assembly 618 captures a visual image of the position and/ororientation of transducer 602 with respect to the patient treatmentarea, and transmits the visual image to the control system 600, also viadata cable 620. The treatment area comprises the region of interest thatthe practitioner has determined the scanning will occur using thetransducer 602.

Once the control system 600 receives the visual position and/ororientation images from imaging device 616 and the transducer image fromtransducer 602, the processing unit 608 suitably processes the imagesfor further display and use. In addition, the images can be suitablytransmitted to memory unit 606 for storage and later reference, forexample, for training purposes or for use later with the same patient orother patients. During processing of the images by processing unit 608,the visual and transducer images can be suitably correlated into acombined image such that the resulting combined image comprises both theultrasonic, acoustic and/or thermal treatment image information capturedby the transducer 602 during operation and the positional imagedepicting the position and/or orientation of the transducer 602 on thesurface of the treatment area at the time the transducer image iscaptured. Once the visual and transducer images are processed by centralprocessing unit 608, such as by a suitable algorithm, the respectivevisual and transducer images, and/or the combined image, i.e., the fusedimage, can be sent to memory unit 606 for storage and later reference.In addition, the respective images and/or the combined image can befurther transmitted to the display device 610 for interpretation by themedical practitioner.

In accordance with another exemplary embodiment, the medical treatmentand diagnosis system can include other visual imaging devices forcapturing information regarding the position and/or orientation of thepatient and the transducer. For example, other imaging devices orcameras can be located with the system, such as a probe assembly havingtwo or more arm members suitably connected to two or more visual imagingdevices. This configuration could provide different views of theposition and/or orientation of the transducer, or even a threedimensional view if desired. In addition, additional imaging devicescould be included from within or proximate the control system ordisplay, such as an additional visual imaging device 680. Moreover,other systems for determining the position of a medical instrument, suchas the triangulation methods described above, can be combined with theprobe assembly of the present invention.

The positional and/or orientation image and the transducer image can beconfigured in various manners. For example, display 610 can beconfigured to display each image separately, for example, on anindividual screen basis, or on the same screen, such as a split screenor a “picture-in-picture” concept as is utilized on various televisionor computer monitors. In addition, in accordance with an exemplaryembodiment, the images can be configured in a combined image whichfacilitates the analysis and assessment of the image information duringor after operation.

With reference to FIG. 7, and with continued reference to FIG. 6, acombined image in accordance with an exemplary embodiment isillustrated. In this embodiment, display device 610 suitably displays acombined image comprising a positional image 734, representative of theposition and/or orientation of transducer 602, and a transducer image732, such as the ultrasonic images of the treatment region received andprocessed by the central processing unit 608. In addition, therespective images can be suitably combined into a single image. Forexample, the single image can include positional rage 734 with an inlayof transducer image 732, i.e., positional image 734 and transducer image732 are suitably fused into a combined image which is representative oftransducer 602 while in contact with the treatment area 736. In otherwords, the combined image can show the region of interest that is imagedunder the patient's skin as represented by the transducer image 732, incorrelation with the position and/or orientation of transducer 602 incontact with the patient's skin, as represented by positional image 734.As a result, a medical practitioner can view the combined image as if across-sectional view of the treatment region is available forassessment, i.e., the combined image is similar to a cross-sectionalview of the patient and the treatment region. For example, withreference to FIG. 10, as transducer 602 is obtaining an ultrasonic imageof a patient's heel, leg or foot 650, a combined image displaying theposition and orientation of transducer fused together with a suitablyscaled ultrasonic image of patient 650 is provided. Moreover, astransducer 602 is moved about the patient, the combined image can besuitably scaled on a real-time basis by software algorithms withincontrol system 600, such as described above. As will be discussed below,such a combined image provides various advantages.

As illustrated in FIG. 8 and FIG. 9, in accordance with the presentinvention, control system 600 is also capable of generating variousother combined image configurations, such as, split-screen images or“picture-in-picture” images. For example, FIG. 8 illustrates a combinedimage wherein the combined image comprises the primary image andincludes an additional inlay of the transducer image 832 comprising asecondary image. Further, with reference to FIG. 9, a combined image isillustrated that includes the transducer image 932 being central to thedisplay device 912 screen as a primary image, and a secondary imagebeing included wherein the secondary image represents the combinedtransducer image 932 and positional image 934 as the secondary image. Itshould be noted that other variations of the images, including differentsizes, locations or types, such as two-dimensional or three-dimensionalimages, can be suitably displayed in accordance with various otherembodiments of the present invention.

As a result of the imaging information provided, medical practitionerscan utilize the information to facilitate the treatment and diagnosis oftheir patients. In addition, the information can be utilized in variousmanners. For example, as the medical treatment and diagnosis system isutilized and imaging information is being observed, a medicalpractitioner can obtain a real-time assessment of the correlationbetween the position and/or orientation of the transducer and theimaging, temperature or therapeutic effects provided by the transducerfor the treatment region. Accordingly, the medical practitioner canutilize the system to guide the transducer to desirable positions on thepatient's surface to obtain the desired treatment or imaginginformation.

In addition, as the information is received, the control system cansuitably store the imaging information in a database for later use andretrieval. For example, it is often difficult when treating patients onsubsequent visits to repeat the ultrasonic treatment, imaging, ormeasurements obtained from prior visits. However, through use of themedical treatment and diagnosis system of the present invention, medicalpractitioners can realize repeatability and consistency in theirtreatment of previous patients.

Moreover, the information captured and stored by the control system canalso be utilized as a guidance tool with respect to new or differentpatients. For example, if a particular position on a patient, forexample, a fixed distance from a patient reference point, yieldsfavorable or desired results, medical practitioners can utilize thesystem to suitably re-position the transducer to the ideal or desiredposition for obtaining similar results. Further, the system can beutilized to train medical practitioners as to the most suitablepositions for the transducer depending on the medical operation to beperformed. For example, a video stream demonstrating 10 to 15 seconds ofoperation of a transducer through display of a combined image candemonstrate appropriate techniques for scanning of a treatment region.

In addition to storing the information, the control system can also beconfigured to process the information, such as through variousalgorithms and the like, to further improve the treatment process. Forexample, various artificial intelligence and other system learningfunctions can be implemented to provide an ever-improving system forfacilitating treatment of patients.

The present invention has been described above with reference to variousexemplary embodiments. However, those skilled in the art will recognizethat changes and modifications may be made to the exemplary embodimentswithout departing from the scope of the present invention. For example,the various operational steps, as well as the components for carryingout the operational steps, may be implemented in alternate waysdepending upon the particular application or in consideration of anynumber of cost functions associated with the operation of the system,e.g., various of the steps may be deleted, modified, or combined withother steps. Further, it should be noted that while the visual imagingsystem is described above is suitably for use by a medical practitionerproximate the patient, the system can also be accessed remotely, i.e.,the medical practitioner can view through a remote display havingimaging information transmitted in various manners of communication,such as by satellite/wireless or by wired connections such as IP ordigital cable networks and the like, and can direct a local practitioneras to the suitably placement for the transducer. These and other changesor modifications are intended to be included within the scope of thepresent invention, as et forth in the following claims.

We claim:
 1. A non-invasive treatment and imaging system comprising: ahand-held probe assembly comprising a transducer operable to obtainpatient information and to provide treatment to a patient, the hand-heldprobe assembly comprising an external surface; an imaging deviceattached to the hand-held probe assembly to track movement of thetransducer, the imaging device operable to capture positional and/ororientation information of the transducer with respect to a surface onthe patient; a rigid member attaching the imaging device to the externalsurface of the hand-held probe assembly, the rigid member configured toposition the imaging device at a fixed distance from the transducerduring the capturing of the positional and/or orientation information ofthe transducer; and a control system in communication with thetransducer and the imaging device, the control system configured toreceive corresponding patient information and positional and/ororientation information of the transducer, the control system furtherconfigured to correlate, fuse, and/or combine the corresponding patientinformation and positional and/or orientation information of thetransducer.
 2. The non-invasive treatment and imaging system of claim 1,the external surface of the probe assembly further comprising apositioning indicator.
 3. The non-invasive treatment and imaging systemof claim 1, wherein the imaging device is a visual imaging device. 4.The non-invasive treatment and imaging system of claim 3, wherein thevisual imaging device is a video camera.
 5. The non-invasive treatmentand imaging system of claim 1, wherein the transducer is an ultrasoundtransducer.
 6. The non-invasive treatment and imaging system of claim 1,wherein the transducer is a combined ultrasound imaging, therapy, andtemperature monitoring transducer.
 7. The non-invasive treatment andimaging system of claim 5, wherein the patient information is anultrasound image.
 8. The non-invasive treatment and imaging system ofclaim 1, the external surface of the hand-held probe assembly comprisinga series of marks.
 9. The non-invasive treatment and imaging system ofclaim 8, wherein the series of marks facilitates scaling of images bythe control system, the images acquired by the imaging device duringchanges in position of the transducer.
 10. The non-invasive treatmentand imaging system of claim 8, wherein the series of marks comprisestriangulation marks.
 11. The non-invasive treatment and imaging systemof claim 1, the external surface of the handheld probe assemblycomprising an electromagnetic device.
 12. The non-invasive treatment andimaging system of claim 11, wherein the electromagnetic devicefacilitates scaling of images by the control system, the images acquiredby the imaging device during changes in position of the transducer. 13.The non-invasive treatment and imaging system of claim 1, the handheldprobe assembly comprising an accelerometer.
 14. The non-invasivetreatment and imaging system of claim 13, wherein the accelerometerfacilitates scaling of images by the control system, the images acquiredby the imaging device during changes in position of the transducer.